Director, QA Microbiology (Drug Product MFG)

We are currently looking to fill a Director QA Microbiology position. This position is the lead for the Regeneron Fill Finish Facility will lead a team of QA Microbiology professionals. This role is responsible for working with management to drive and implement policy to ensure all protocol and SOPs are aligned.

In this role, a typical day might include the following:

• Organization Management and Support of QA for Microbiology:

  • Lead team members in all aspects of QA Microbiology and performance management

• Drug Product Final Fill Operational Microbial Control Oversight:

  • Make decisions, develop and influence policies related to microbial control

  • Observe microbial and aseptic practices in classified areas and propose improvements

  • Resolve problems, identify trends, and make system improvements

  • Maintain current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations

  • Support the review of microbial control related documents, including but not limited to, SOPs, Validation and Qualification documentation, Study Protocols, technical documents, work instructions, Instructor Led Trainings (ILCs), and On-The-Job Trainings (OJTs)

  • Provide technical expertise for investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plan development, product impact assessment and remediation plans

  • Analyze Environmental Monitoring (EM) data and provide guidance for trending

  • Create microbial and aseptic training scenarios and presentations including, but not limited to, hands-on simulated production scenarios, presentations regarding process steps, job expectations and regulatory requirements and general information intended to expedite development of personnel

• Support CMO Microbial Control Oversight and Investigations:

  • Serve as the microbiology authority for CMOs

  • Serve as the microbiology guide in quality audits of CMOs, provide information to aid in the generation of audit reports

• Collaborate with QA Microbiology Leadership and Cross Functional Teams:

  • Foster collaborative working relationships between Regeneron departmental representatives

  • Serve as a subject matter expert (SME) to present topics to management and during inspections

  • Maintain consistency of IOPS Microbial programs and initiatives across multiple sites through procedures and education of personnel

• Regulatory Inspection Preparation:

  • Perform facility walkthroughs as needed for inspection readiness

  • Support logistics associated with regulatory inspections

  • Effectively communicate concerns to leadership

  • Provide guidance for responding to inspection findings and communicate updates, metrics and outstanding items to senior personnel

• Ability to travel domestically and internationally 10% or less

This role may be for you if you:

• Have experience in quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals

• Excel in a quality driven organization

• Have an understanding of biologics manufacturing operations

To be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and the following amount of related experience, preferably in the pharmaceutical or biotech industries or related field, for each level:

• Associate Director – 10+ years

• Director – 12+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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